HIV-infected children from sub-Saharan Africa often present with severe malnutrition. In severe malnutrition, metabolic and/or gut structural derangement may lead to inadequate antiretroviral (ARV) absorption and/or erratic drug levels. The greater surface area to weight ratio in severely malnourished children could also place them at higher risk of under dosing compared to children with mild to moderate malnutrition. However, limited data are available on the pharmacokinetics of ARVs in severely malnourished children. This study will address this critical gap in knowledge by evaluating the PK of zidovudine (ZDV), lamivudine (3TC), and lopinavir/ritonavir (LPV/r) in severely malnourished children, compared to children with normal nutrition to mild malnutrition.

To compare the minimum trough concentration of LPV/r between severely malnourished children and children with normal nutrition - mild malnutrition at 1, 4, 8, 12, 16, 24, 36 and 48 weeks following initiation of HAART

LPV protein binding comparison between severely malnourished children with children with normal/mild malnutrition [ Time Frame: 1, 12 and 24 weeks following study entry ] [ Designated as safety issue: No ]

To investigate the impact of malnutrition on LPV protein binding by comparing the free fraction of LPV in severely malnourished children and children with normal nutrition - mild malnutrition at 1, 12 and 24 weeks.

Parent or legal guardian able and willing to provide signed informed consent, remain within the study area during the study period and agree to have subject followed at the clinical site

Qualifying hematology and chemistry laboratory values obtained from specimens collected within the study-specific screening period

For severely malnourished children: An inpatient in a nutrition rehabilitation unit. Clinical improvement after 10-18 days on nutrition rehabilitation defined as: Appetite returned and eating better - child shows interest in food even if does not complete amount given:

No further weight loss

Normalized sodium and potassium defined as severity grade 1 or lower

No evidence of cardiac failure

Loss of apathy and starting to play

No hypothermia or pyrexia - temperature stable at >35.0 to <38.0° C (non-axillary) or >34.4 to <37.4° C (axillary)

For children with normal - mild malnutrition, clinical stability will be indicated by:

Good appetite

Normalized sodium and potassium defined as severity grade 1 or lower

No hypothermia or pyrexia - temperature stable at >35.0 to <38.0° C (non-axillary) or >34.4 to <37.4° C (axillary)

Acute infection for which the child has received appropriate antimicrobial treatment for <5 days

Tuberculosis disease

Clinic hepatitis as evidenced by jaundice and hepatomegaly

Taking any disallowed medications

Any condition, situation, or clinical finding that in the opinion of the investigator would place the child at an unacceptable level of risk for injury, or render the child/caregiver(s) unable to meet the requirements of the study, interfere with study participation, or in the interpretation of study results.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01818258